Cytokinetics(CYTK) GlobeNewswire·2025-05-18 12:00Core Insights - The analyses from SEQUOIA-HCM demonstrate that aficamten has a consistent effect on exercise capacity, symptoms, hemodynamics, and cardiac biomarkers in patients with obstructive HCM, regardless of baseline symptom severity and geographic region [2][4] Group 1: Aficamten Efficacy in Different Symptom Severity - In the SEQUOIA-HCM trial, patients with mild symptoms (n=118) and moderate-to-severe symptoms (n=150) showed similar improvements in peak oxygen uptake (pVO2) with changes of 1.6 mL/kg/min and 1.8 mL/kg/min respectively [3] - The improvement in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) was greater in the moderate-to-severe symptom group compared to the mild symptom group, with an interaction p-value of 0.02 [3] - At the end of treatment, 54% of patients with mild symptoms and 36% of those with moderate-to-severe symptoms were asymptomatic, indicating a positive response to aficamten across symptom severities [3] Group 2: Aficamten Efficacy Across Geographic Regions - The SEQUOIA-HCM trial included patients from Europe (n=142), North America (n=94), and China (n=46), with no significant differences in the effect of aficamten on pVO2 and secondary endpoints across these regions [4] - Baseline characteristics varied, with North American patients generally older and having higher BMI and comorbidities compared to those in Europe and China [4] - The safety profile of aficamten was consistent across regions, with similar incidences of serious adverse events and infrequent occurrences of left ventricular ejection fraction (LVEF) <50% [4] Group 3: Real-World Data on Non-Obstructive HCM - A retrospective cohort study of 9,842 patients with non-obstructive HCM revealed that female patients had higher rates of stroke (RR 1.32), heart failure (RR 1.22), and cardiovascular hospitalization (RR 1.23) compared to male patients [5] - Older patients (75 years or older) had the highest all-cause mortality rate at 16.6%, emphasizing the need for effective treatments in this demographic [5] - The study highlights disparities in morbidity and survival among females and older patients with non-obstructive HCM, suggesting a potential market for novel treatments [5] Group 4: About Aficamten - Aficamten is a selective cardiac myosin inhibitor designed to reduce myocardial hypercontractility associated with HCM, showing promise in improving exercise capacity and relieving symptoms [6][7] - The drug has received Breakthrough Therapy Designation from the FDA for symptomatic HCM and is currently under regulatory review in the U.S. and Europe [9][12] - Aficamten is also being evaluated in multiple clinical trials, including those for non-obstructive HCM and pediatric populations [8][12]